Notice2022-09628
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Retailer Training Programs
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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 5, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions associated with "Tobacco Retailer Training Programs."
Full Text
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<title>Federal Register, Volume 87 Issue 87 (Thursday, May 5, 2022)</title>
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[Federal Register Volume 87, Number 87 (Thursday, May 5, 2022)]
[Notices]
[Pages 26766-26768]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09628]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0350]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Tobacco Retailer Training Programs
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions
associated with ``Tobacco Retailer Training Programs.''
DATES: Submit either electronic or written comments on the collection
of information by July 5, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 5, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 5, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2010-D-0350 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Tobacco Retailer Training
Programs.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts
[[Page 26767]]
and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
<a href="/cdn-cgi/l/email-protection#feaeacbfad8a9f9898be989a9fd096968dd0999188"><span class="__cf_email__" data-cfemail="025250435176636464426466632c6a6a712c656d74">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Tobacco Retailer Training Programs
OMB Control Number 0910-0745--Extension
Tobacco products are governed by chapter IX of the Federal Food,
Drug, and Cosmetic Act (sections 900 through 920) (21 U.S.C. 387
through 21 U.S.C. 387u). The FDA intends to issue regulations
establishing standards for approved tobacco retailer training programs
under section 906(d) of the Federal Food, Drug and Cosmetic Act (21
U.S.C. 387f(d)). In the interim, FDA published a guidance document
which can be downloaded at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tobacco-retailer-training-programs">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tobacco-retailer-training-programs</a>. The
guidance is intended to assist tobacco retailers to voluntarily
implement effective training programs for employees.
The guidance discusses recommended elements that should be covered
in a training program, such as: (1) Federal laws restricting the access
to, and the advertising and promotion of, cigarettes, smokeless, and
covered tobacco products; (2) the health and economic effects of
tobacco use, especially when the tobacco use begins at a young age; (3)
written company policies against sales to youth and other restrictions
on the access to, and the advertising and promotion of, tobacco
products; (4) identification of the tobacco products sold in the retail
establishment that are subject to the Federal laws and regulations
prohibiting their sale to underage persons; (5) age verification
methods; (6) practical guidelines for refusing sales; and (7) testing
to ensure that employees have the required knowledge. The guidance
recommends that retailers require current and new employees to take a
written test prior to selling tobacco products and that refresher
training be provided at least annually and more frequently as needed.
The guidance recommends that retailers maintain certain written records
documenting that all individual employees have been trained and that
retailers retain these records for 4 years in order to be able to
provide evidence of a training program during the 48-month time period
covered by the civil money penalty schedules outlined in the law.
The guidance also recommends that retailers implement certain
hiring and management practices as part of an effective retailer
training program. The guidance suggests that applicants and current
employees be notified both verbally and in writing of the importance of
complying with laws prohibiting the sales of tobacco products to
underage persons. In addition, FDA recommends that retailers implement
an internal compliance check program and document the procedures and
corrective actions for the program.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity; guidance section IV Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Develop training program........ 79,700 1 79,700 16 1,275,200
Develop written policy against 79,700 1 79,700 1 79,700
sales to youth and employee
acknowledgement................
Develop internal compliance 79,700 1 79,700 8 637,600
check program..................
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Total....................... .............. .............. .............. .............. 1,992,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 26768]]
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
Activity; guidance section IV Number of records per Total annual Average burden per recordkeeper Total hours
recordkeepers recordkeeper records
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Training program.......................... 79,700 4 318,800 0.25 (15 minutes)........................... 79,700
Written policy against sales to youth and 79,700 4 318,800 0.10 (6 minutes)............................ 31,880
employee acknowledgement.
Internal compliance check program......... 79,700 2 159,400 0.5 (30 minutes)............................ 79,700
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Total................................. .............. .............. .............. ............................................ 191,280
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA's estimate of the number of respondents in tables 1 and 2 is
based on data from the deeming rule Final Regulatory Impact
Analysis,\1\ which showed there are an estimated 362,273 retail
establishments that currently sell tobacco products. The Agency
reviewed these numbers again for this notice, and believe they are an
accurate estimation. We assume that 75 percent of tobacco retailers
already have some sort of age and identification verification training
program in place. We expect that some of those retailer training
programs already meet the elements in the guidance, some retailers
would update their training program to meet the elements in the
guidance, and other retailers would develop a training program for the
first time. Thus, we estimate that two-thirds of tobacco retailers
would develop a training program that meets the elements in the
guidance (66 percent of 362,273 = 239,100; then annualized to 79,700).
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\1\ Deeming Tobacco Products to be Subject to the Food, Drug,
and Cosmetic Act, as Amended by the Family Smoking Prevention and
Tobacco Control Act: Final Regulatory Impact Analysis, 2016 <a href="https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM500254.pdf">https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM500254.pdf</a>.
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We have adjusted our burden estimate and the number of respondents,
which has resulted in a decrease to the currently approved burden and
respondent count. This adjustment is based on available data estimating
the number of retail establishments that sell tobacco products in the
United States. Additionally, the burden chart was updated to reflect a
change from an estimation over the course of 3 years to annualized
burden.
Dated: April 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09628 Filed 5-4-22; 8:45 am]
BILLING CODE 4164-01-P
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